AB1092 GUSELKUMAB RAPIDLY IMPROVES ACTIVITIES OF DAILY LIVING IN PATIENTS WITH ACTIVE PSA: POOLED ANALYSIS OF 2 PHASE 3, RANDOMIZED, PLACEBO-CONTROLLED STUDIES
Authors: P. Rahman, C. Selmi, E. Rampakakis, M. Sharaf, M. Shawi, N. Shiff, M. Strauss, C. Han, P. J. Mease, J. Curtis, M. E. Husni
Journal: Annals of the Rheumatic Diseases (2023)

<h3>Background</h3> Maintaining daily activities is a critical treatment goal for patients (pts) with psoriatic arthritis (PsA). The Health Assessment Questionnaire-Disability Index (HAQ-DI), a mainstay tool for evaluating physical function in pts with PsA, assesses 20 common activities of daily living that should be evaluated given the heterogeneous clinical presentation of PsA. <h3>Objectives</h3> In this post hoc analysis from DISCOVER (D)-1 and -2, we examined the level of impairment in individual activities of daily living assessed by the HAQ-DI, and the effect of guselkumab (GUS) on pts' ability to accomplish these activities, among pts with active PsA. <h3>Methods</h3> D1/D2 enrolled adults with active PsA despite standard therapies. D1 pts had ≥3 swollen and ≥3 tender joints (SJC/TJC), C-reactive protein (CRP) ≥0.3 mg/dL; 31% had 1-2 prior TNF inhibitors (TNFi). D2 pts had ≥5 SJC/TJC and CRP ≥0.6 mg/dL; all were biologic-naïve. Pts were randomized 1:1:1 to GUS 100 mg every 4 weeks (Q4W); GUS 100 mg at W0, W4, then Q8W; or placebo (PBO). Scores for each of the 20 HAQ-DI items (range: 0-3; 0/1/2=no/some/much difficulty, 3=unable to do) at baseline (BL) and proportion of pts with scores ≥1 or ≥2 were summarized. Ability to achieve ≥1-level or ≥2-level improvement in each HAQ-DI item (in pts with BL score ≥1 or ≥2, respectively) during the 24W PBO-controlled period was compared between GUS- and PBO-treated pts using logistic regression adjusting for BL value, prior TNFi use, and BL DMARD use. <h3>Results</h3> At BL, the mean (SD) HAQ-DI score=1.2-1.3 (0.6) across treatment groups. The majority of pts (84.5%) had a score &gt;0.5, indicating some functional limitation, and reported impairment in one or more activity, with the greatest impact on ability to do chores, dress oneself, and get in/out of bed (Table 1). The proportion of pts achieving ≥1-level improvement across HAQ-DI items was significantly higher with GUS vs. PBO as early as W4 and increased through W24 (Figure 1). Similar patterns were observed for achieving a ≥2-level improvement across HAQ items (data not shown). Responses were numerically similar between GUS Q4W and Q8W. <h3>Conclusion</h3> In the setting of PsA, GUS demonstrated improvements as early as W4 across all HAQ-DI items, including those most impaired at BL, with comparable responses between dosing regimens. These findings may assist the communication between pts and healthcare providers when establishing treatment goals during shared decision making. <h3>REFERENCES:</h3> NIL. <h3>Acknowledgements:</h3> NIL. <h3>Disclosure of Interests</h3> Proton Rahman Consultant of: AbbVie, Amgen, Bristol Myers Squibb, Celgene, Eli Lilly, Janssen, Merck, Novartis, Pfizer, and UCB, Grant/research support from: Janssen and Novartis, Carlo Selmi Speakers bureau: AbbVie, Amgen, Alfa-Wassermann, Biogen, Eli Lilly, Galapagos, Janssen, Novartis, SOBI, Consultant of: AbbVie, Amgen, Alfa-Wassermann, Biogen, Eli Lilly, Galapagos, Janssen, Novartis, SOBI, Grant/research support from: AbbVie, Amgen, Pfizer, Emmanouil Rampakakis Consultant of: Janssen, Employee of: JSS Medical Research, Mohamed Sharaf Employee of: Janssen MEA, Dubai United Arab Emirates, May Shawi Shareholder of: Johnson &amp; Johnson, Employee of: Janssen Pharmaceutical Companies, Natalie Shiff Shareholder of: AbbVie, Gilead, Iovance, Jazz Pharmaceuticals, Johnson &amp; Johnson, Novavax, and Viatris, Employee of: Janssen Scientific Affairs, LLC, Marcie Strauss Consultant of: Janssen Scientific Affairs, LLC, Employee of: Medasource, Chenglong Han Shareholder of: Johnson &amp; Johnson, Employee of: Janssen Research &amp; Development, LLC, Philip J Mease Speakers bureau: AbbVie, Amgen, Eli Lilly, Janssen, Novartis, Pfizer, Sun Pharma, and UCB, Consultant of: AbbVie, Aclaris, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Galapagos, Gilead, GlaxoSmithKline, Inmagene, Janssen, Novartis, Pfizer, Sun Pharma, and UCB, Grant/research support from: AbbVie, Amgen, Bristol Myers Squibb, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer, Sun Pharma, and UCB, Jeffrey Curtis Consultant of: AbbVie, Amgen, Bristol-Myers Squibb, CorEvitas, Eli Lilly and Company, Janssen, Myriad, Novartis, Pfizer, Sanofi, and UCB., Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, CorEvitas, Eli Lilly and Company, Janssen, Myriad, Novartis, Pfizer, Sanofi, and UCB, M Elaine Husni Consultant of: AbbVie, Amgen, Bristol-Myers Squibb, Janssen, Sanofi Genzyme/Regeneron, UCB, Novartis, and Eli Lilly.